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Active, Not Recruiting

NCT Number: NCT02526082

Long-term Follow-up of the Helsinki Businessmen Study

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a "life-course" study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion criteria

  • Non-participants

Treatment and study plan

Intervention

Other

Multifactorial intervention with lifestyle changes and drugs as needed

Primary outcomes

  1. Total mortality: national registers

    Time frame: change from baseline up to 612 months

Secondary outcomes

  1. Health-related quality of life: questionnaire data

    Time frame: change from baseline up to 612 months

  2. Geriatric syndromes and disability: questionnaires, clinical examinations, registers

    Time frame: change from baseline up to 612 months

  3. Morbidity: self-report, national registers, hospital and autopsy records

    Time frame: change from baseline up to 612 months

  4. Medications: self-report, national registers

    Time frame: change from baseline up to 612 months

  5. Cause-specific mortality: national registers, autopsy records

    Time frame: change from baseline up to 612 months

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Long-term Follow-up of the Helsinki Businessmen Study Cohort of Men Born in 1919-1934

Acronym: HBS

Important dates

Study start
1964
Primary completion
2040
Study completion
2040
First posted
Aug 18, 2015
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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